Kornimate/medical-research-clean huggingface dataset:
switching from consta® to sustenna® in patients with schizophrenia

Conditions: Schizophrenia

Summary: the aim of this study is observation of effectiveness and side effect of patients with schizophrenia who will switch the antipsychotics from risperidone long acting injection to paliperidone palmitate.

in this study, investigators are going to enroll the patients who will switch the risperidone long acting injection to paliperidone palmitate. and investigators will examine the effectiveness and side effect of paliperidone palmitate. in addition, effectiveness and side effect related variables will be studied.

Eligibility criteria:
inclusion criteria: * age: 18 \~ 65 * patient with schizophrenia according to dsm-iv criteria * patient have signed on the informed consent, and well understood the objective and procedure of this study. * maintenance therapy more than 6 months with risperidone long acting injection monotherapy or other with concomitant antipsychotics, and stable dose of risperidone long acting injection was maintained 8 weeks more. the stable dose of other antipsychotics has been maintained 8 months and more. * patient wants to switch antipsychotics to paliperidone palmitate. * panss total score ≤ 80 * each score of conceptual disorganization(p2), hallucinatory behavior(p3), suspiciousness/persecution(p6), unusual thought content(g9)in panss ≤ 4 * competent patient who is manage to answer the questionnaires. * in case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study. exclusion criteria: * no history of antipsychotics use. * past history of nms. * allergy or hypersensitivity to risperidone or paliperidone er. * concomitant antipsychotics was oral risperidone or paliperidone er. * initiating or dose-changing of ssri, maoi, tca within 2 months(maintenance is allowed if those have been stable for at least 30days prior to study entry and would not be any dose changes during the study) * initiating of lithium, valproic acid, carbamazepine, topiramate, lamotrigine or other mood stabilizer within 2months (maintenance is allowed). * patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion. * current substance dependence(dsm-iv) or past history of dependence (more than 6months) * significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion. * history of cardiac disease which predispose to qt prolongation(sick sinus, complete av block, chf, ventricular tachycardia, hypokalemia or hypocalcemia) or current medication of qt prolonging drugs * pregnant or breast-feeding female patient. * history of participating to other investigational drug trial within 1month prior to screening. * investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator

Keywords: paliperidone palmitate switching schizophrenia subjective well-being
cardiovascular and torsades de pointes monitoring for pazopanib

Conditions: Carcinoma, Renal Cell

Summary: this observational study is conducted as part of a systematic pharmacovigilance activity, to provide a population-based context for pazopanib use outside of the clinical trial setting. the aims of the study are to examine the incidence of cardiovascular ischemia (including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident) and cardiac arrhythmia (torsades de pointes) in renal cell carcinoma patients treated with marketed anti-vegf agents \[pazopanib (votrient), bevacizumab (avastin), sorafenib (nexavar), and sunitinib (sutent)\]. two databases will be utilized for this study: a large healthcare claims database in the u.s. and the dutch linked medical registries (pharmo rls). the databases will provide large, geographically varied, non-trial populations in which to examine the incidence of the stated cardiovascular ischemic events and torsades des pointes.


Eligibility criteria:
inclusion criteria: the anti-vegf cohorts will include patients with the following characteristics: * adult patients (age ≥18 years) * prescribed or administered an anti-vegf agent: pazopanib, bevacizumab, sorafenib or sunitinib on or after approval date of pazopanib * diagnosed with renal cell cancer exclusion criteria: * patients with multiple primary cancer diagnoses

Keywords: adverse events pazopanib torsades des pointes renal cell carcinoma anti-vegf agents observational data cardiac ischemia
clinical evaluation of toric intraocular lens made by aurolab

Conditions: Astigmatism

Summary: the purpose of this study is to measure visual acuity and intraocular lens (iol) rotational stability after implantation of toric iol and to assess the post operative complications after implantation of toric iol.

among available methods for treating astigmatism in cataract surgery, the implantation of toric iols is an emerging technology that shows promising results. similar to implanting a one-piece acrylic lens, toric iols provide good distance vision and, in many patients, freedom from spectacles for distance vision. a low absolute residual refractive cylinder has been associated with the implantation of toric iols, and the safety profile for toric iols has been good. as improvements with regard to rotational stability and treatment and cylinder power range are made, toric iols will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery. further, to evidence on the safety and efficacy of toric iol for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of toric iol implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.

Eligibility criteria:
inclusion criteria: * age 40 to 65 * senile cataract * posterior sub capsular cataract (pscc) * astigmatism 1.25 d or more * residence within 100 kms of madurai exclusion criteria: * traumatic \& complicated cataract * poor mydriasis * amblyopia * severe pseudo exfoliation (pxf) * dense posterior polar cataract (ppc) * one eyed patients * uveitis * corneal pathology / scar * retinal pathology contributing to visual loss * intraoperative complication like pc rupture, zonular dialysis
sacral chordoma: surgery versus definitive radiation therapy in primary localized disease

Conditions: Chordoma

Summary: comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma

international, multicenter, comparative, open-label, parallel-group, mixed observational-randomized controlled trial. all the patients, who are candidate for the study will receive full information on the characteristics, potential effectiveness and side effects of the two alternatives treatments: radiotherapy (rt) and surgical treatment eligible patients will be asked to be randomized in order to receive treatment a (surgery, with or without rt) or treatment b (definitive rt) who will refuse randomization will be included in the prospective cohort study (pcs) and will be treated accordingly to their choice (treatment option a or treatment option b). the same radiotherapy and surgical regimen will be administered in the pcs and in the randomized clinical trial (rct) cohort

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from s1 to coccyx. * age≥18years * ecog-performance status (ps) 0-2 * no previous antineoplastic therapy * macroscopic tumor detectable at mri/ct scan * patient amenable for surgery * patient amenable for rt * written informed consent given before the enrolment, according to international conference on harmonisation/good clinical practice (ich/gcp). exclusion criteria: * distant metastasis * inability to maintain treatment position * prior radiotherapy to the pelvic region * prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc) * local conditions that increase the risk of rt toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field) * rectal wall infiltration * general conditions that increase the risk of rt toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria) * presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia) * severe comorbidities resulting in a prognosis of less than 6 months * inability to give informed consent * other malignancy within the last 5 years * performance status ≥ 2 (ecog). * significant cardiovascular disease (for example, dyspnea \> 2 nyha) * significant systemic diseases grade \>3 on the nci-ctcae v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity * women who are pregnant or breast-feeding * psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent
cracking the heterogeneity of social outcome through neuropsychophysiological profiles

Conditions: Schizophenia Disorder

Summary: crheso aims at overcoming the considerable burden of mental disorders, which affects both psychosocial well-being and societal welfare, through a multidisciplinary and integrated approach to explore and remediate dimensions affecting social outcome.

social functioning is fundamental for human adaptation, relationships, and psychological well-being. schizophrenia, a severe psychiatric disorder, is one of the leading causes of disability worldwide and presents significant challenges in social interactions for those affected, increasing the risk of isolation and marginalization. the crheso project aims to analyze the factors influencing social functioning. the main hypothesis is that social functioning depends on various components, including neurocognitive, sociocognitive, and language abilities, along with their electrophysiological markers. crheso seeks to characterize neuropsychophysiological profiles (combining neuropsychological and electrophysiological data) to better understand social outcomes in individuals with schizophrenia and in healthy subjects. the investigators will address the following objectives: * primary objective: primary objective: to disentangle social functioning complexity in schizophrenia and healthy controls by characterizing neuropsychophysiological profiles linked to levels of social disruption * secondary objective: to improve factors associated with social outcome and explore changes in neuropsychophysiological markers the investigators will enroll 50 schizophrenic patients and 50 healthy controls. participants will undergo an initial visit with a specialist psychiatrist who will verify that their conditions meet the criteria required by the study. then, subjects will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel eeg. to test if the factors associated with social dysfunction in schizophrenia can be restored, we will propose to subjects with schizophrenia to participate in a rehabilitative training. those who choose not to undergo the training will only participate in the cross-sectional study, while 10 patients who decide to participate in the training will undergo cognitive remediation training (cognitive remediation), already published and demonstrated to be feasible for patients with schizophrenia. in the check-up visits (i.e., after the training), the patients enrolled in the treatment group, will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel eeg.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * diagnosis of schizophrenia according to dsm v criteria * ability to provide informed consent exclusion criteria: * intellectual disability * neurological disorder

Keywords: electrophysiology metaphor comprehension language disorder social functioning
xydalba utilization registry in france

Conditions: Bacterial Infections

Summary: this observational study will collect data on the use of the drug xydalba® in daily clinical practice in france. such observational studies are also referred to as registries. the sponsor of the study is correvio international sárl, based in switzerland. xydalba® contains the active substance dalbavancin, a remedy for a certain type of bacterial pathogens (so-called "gram positive bacteria") which cause the disease. active ingredients against bacteria are also called antibiotics. correvio wants to know which patients received the drug and how the disease went. the treatment places where you got xydalba, ie clinic, intensive care unit or elsewhere should be recorded. in addition, it is important in this type of medication to track whether the pathogens are changing in any way. any safety-relevant events (such as side effects) that have occurred during treatment should be investigated by the sponsor and submitted to the competent european authorities.

objectives the objectives of this registry are as follows: * to determine the following characteristics in patients who received intravenous xydalba administration: * patient characteristics. * disease characteristics. * pathogen characteristics. * to characterize the usage of xydalba. * to characterize the patient's residence and, in hospitalized patients, the lengths of hospital and intensive care unit (icu) stays, and the destination upon hospital discharge. * to assess the response of xydalba treatment, based on clinician determination. * to characterize the major healthcare resource utilization (hru) of patients treated with xydalba. registry design: this is a multicenter, prospective registry of adult patients treated with xydalba in france. all adverse events (aes) (serious and non-serious; special situations; related and not-related, collected prospectively or retrospectively) will be recorded in the ecrf. treatment related aes and saes will be reported to the healthcare authorities, as requested by local regulations and according to current guideline on good pharmacovigilance practices (gvp) module vi - collection, management and submission of reports of suspected adverse reactions to medicinal products (rev 2). test product (s), dose, and mode of administration xydalba (dalbavancin) as prescribed by the physician according to clinical practice. rationale: this prospective registry is designed to capture information about the clinical use of xydalba, its safety and effectiveness, characteristics of the patient, disease, pathogen, clinical course, treatment course, and hospitalization. this registry will capture the data in real world setting on patients who received xydalba.

Eligibility criteria:
inclusion criteria: * male and female patient associate to a social protection scheme, ≥18 years of age at the time of receipt of xydalba * the patient received at least one infusion of xydalba * patient signed the consent form exclusion criteria: * the patient was enrolled in a clinical trial in which treatment for xydalba is managed through a protocol.
community-led action research in oncology: improving symptom management

Conditions: Chemotherapy-induced Neutropenia; Chemotherapy-induced Nausea and Vomiting; Anxiety; Depression; Fatigue; Neoplasms

Summary: this study will be conducted at la liga contra el cancer in san pedro sula, honduras. the overall objective of this project is to improve symptom management for patients undergoing chemotherapy in honduras. the first step in this line of research is a "proof of concept" feasibility study in which the investigators will demonstrate their ability to train nurses to administer a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.

the investigators will use the team's previous experience delivering a standardized, non-pharmacological palliative care intervention by telephone to inform a "proof of concept" feasibility study in honduras. they will train nurses at la liga contra el cancer in san pedro sula to conduct the telephone sessions and monitor their fidelity to treatment as they enroll a minimum they will then evaluate the feasibility, acceptability, and potential effectiveness of the program.

Eligibility criteria:
inclusion criteria: * patients who are over the age of 18 and are beginning a chemotherapy regimen to treat any solid or hematological cancer will be eligible for the study. exclusion criteria: * patients who do not start planned chemotherapy.

Keywords: pain constipation
study of covid-19 outbreak in hospital departments of bamako, mali

Conditions: Covid19

Summary: the new coronavirus known as sars-cov-2 (severe acute respiratory syndrome -coronavirus 2) was first reported in december 2019 and rapidly became a public health emergency. the covid-19 pandemic is now affecting sensitive regions with fragile health care systems, such as south america and africa. caregivers, in the front line of covid19 patient management, may accidentally become infected and a source of infection during the incubation phase or in case of asymptomatic infection. the objectives of this project are thus i) to assess sars-cov-2 spread over the hospital departments of bamako by carrying out a systematic molecular screening of patients and caregivers, ii) to evaluate the feasibility of point-of-care molecular assays in mali and iii) to estimate the immunity acquired from sars-cov-2 among health workers through serological testing, allowing also the assessment of asymptomatic caregiver rate and absence of re-infection among the immunized caregivers. finally, iv) variability of the virus over time and spread of different variants around the world will be studied by sequencing the viral genome.


Eligibility criteria:
inclusion criteria: * free and informed consent accepted in writing * patient: patient hospitalized in one of the four hospitals of bamako, with clinical signs of infection of the upper or lower respiratory tracts (sore throat, cough/sputum, nasal congestion and rhinorrhea, odynophagia, thoracic oppression, dyspnea, desaturation) with fever or feeling of fever or any other signs of sars-cov-2 infection (that is to say the following clinical manifestations, of sudden onset: unexplained asthenia, unexplained myalgia, headache without a known migraine disease, anosmia or hyposmia without associated rhinitis, dysgueusia, diarrhea, heart rhythm disorders, acute myocardial injury, severe thromboembolic event) or who have been in close contact with a sars-cov-2 infected person without effective protective measures (ffp2/surgical masks or physical separation) and defined as follows: having shared the same place of life as the confirmed case, for example: family, same room or having a direct contact in face to face with less than 1 meter from the confirmed case during a talk; intimate friends; class or office neighbours; adjacent to the index case in a plane or a train; or having provided or received hygiene or care acts from a confirmed case. * caregivers: caregivers of one of the four hospitals of bamako exclusion criteria: * persons subject to legal protection or not able to give a free and informed consent. * caregivers: caregivers not able to follow the project schedule

Keywords: covid-19 sars-cov-2 mali africa hospital
cbt augmentation to promote medication discontinuation in pediatric ocd

Conditions: Cognitive Behavioral Therapy; Obsessive-Compulsive Disorder; Obsessive-Compulsive Disorder in Children; Obsessive-Compulsive Disorder in Adolescence

Summary: the purpose of this study is to examine whether youth with ocd who benefit from cbt augmentation to sri can discontinue their medication without relapse over 24 weeks.

pediatric obsessive-compulsive disorder (ocd) is a common, chronic, and severe psychiatric disorder. currently, many youth with ocd are treated with medication, such as a serotonin reuptake inhibitor (sri); however, only a subset of them responds to sri. data show that the addition of cognitive-behavioral therapy (cbt) to sri partial responders is effective although extended sri use with cbt can attenuate combined treatment outcomes. this placebo-controlled study will enroll pediatric ocd patients to examine if those who benefit from cbt augmentation can discontinue their sri successfully without relapse over 24-weeks. this study will also bank genomic samples for future analysis when polygenic risk scores for ocd may become available. this study will be conducted in two phases. in phase i, all participants will receive a web-based cbt for 12 to 18 weeks. at the end of phase i, those who achieve wellness indicated by cy-bocs ≤ 12 and ≥ 50% reduction since baseline for 3 consecutive weeks, will go on to the next phase. in phase ii, participants will be randomized into two groups: 1) continued sri and 2) discontinuation titration to placebo. in this phase, all participants will receive web-based cbt maintenance sessions and attend medication visits for 24 weeks. at 12 months after the end of phase ii, all participants will complete a follow-up assessment.

Eligibility criteria:
inclusion criteria: * the child is between the ages of 7 to 17 at enrollment with a primary diagnosis of ocd of \> 6 months duration based on the kiddie schedule for affective disorders and schizophrenia lifetime version for dsm-5 (ksads-pl) and have a cy-bocs ≥ 16. * the child is on stable and maximally tolerated sri medication (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, citalopram, escitalopram) for ≥12 weeks given that they are persistently and moderately symptomatic. paroxetine is exclusionary due to safety concerns. * both the child and parent participating in the study are english speaking. * both the child and their parent participating in the study reside in texas. exclusion criteria: * the child has a diagnosis of lifetime dsm-5 bipolar disorder, psychotic disorder, and/or intellectual disability. * the child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention. * the child is receiving concurrent psychotherapy for ocd. * initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.
a study to find the best doses of su011248 (sunitinib) and capecitabine when these drugs are administered together

Conditions: Solid Tumors; Breast Cancer; Neoplasms

Summary: this study assesses the maximum tolerated dose, overall safety and antitumor activity of su011248 in combination with capecitabine in patients with advanced solid tumors


Eligibility criteria:
inclusion criteria: * patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists * patient has good performance status (ecog 0 or 1) exclusion criteria: * prior treatment with either su011248 or capecitabine. * hypertension that cannot be controlled by medications

Keywords: solid tumor malignancy, su011248, sunitinib, capecitabine, phase 1